Senior Clinical Trial Manager

Overview

Join a well-established and collaborative Clinical Operations team in a Senior Clinical Trial Manager role with opportunity for career enrichment. As an integral member of the team, the Senior Clinical Trial Manager (CTM) works closely with cross functional team members, clinical research organizations (CROs), and other vendors to ensure clinical trial execution is conducted in accordance with the protocol (including scientific aspects), SOPs, ICH/GCP/regulatory guidelines, and company goals while ensuring timely delivery and budget adherence. Clinical Trial Managers at Celldex maintain highly visible responsibilities and accountability for their projects. This role reports to the Senior Director of Clinical Operations. Frequent travel to the New Haven, CT office is required, as well as occasional travel to clinical trial sites, congresses, and conferences.

Responsibilities

• Comprehensive oversight of operational aspects of assigned clinical trials.
• Scientific aptitude to understand the scientific aspects of the clinical trials to provide effective operational leadership
• Responsible for ensuring compliance with relevant regulations and guidelines by maintaining regular contact with external vendors, including CRO or CRA oversight, as applicable.
• Acting as the Sponsor’s primary point of contact, leads and conducts reviews Completing of monitoring reports and periodic review of data quality. Identifying potential study issues and recommending and implementing solutions or corrective actions as needed.
• Organizing and managing internal cross-functional study team meetings and other trial-specific meetings
• For studies which are outsourced to CRO partners; management of CRO interactions, including sponsor oversight of relevant functional activities (e.g., study management, monitoring, site management, and trial master file). Works with CRO to monitor budgets, plans and detailed timelines, and ensures that performance expectations are met.
• Participating in the development, review and implementation of protocols, clinical study reports, DSURs, IBs and departmental SOPs and processes

Qualifications

• Excellent oral and written communication skills
• Ability to influence without authority
• Strong computer skills including knowledge of Microsoft Excel, Word, and Outlook
• Ability to work within established timelines, in a fast-paced environment
• Excellent organizational and priority management skills
• Strong interpersonal skills

Education/Experience:

• BS/BA degree in science or related discipline.
• 3 – 5 years of prior experience managing clinical trials for or within the biotech or pharmaceutical industry, including direct oversight of CROs, monitoring of budget scope, clinical site monitoring, and knowledge of basic data management/biostatistics processes and pharmacovigilance
• 1-2 years of prior experience leading cross functional clinical trial teams
• Ability to understand and operationalize scientific concepts
• Prior dermatology/allergy experience preferred
• Knowledge of RBQM concepts and implementation preferred
• In-depth knowledge of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines is required
• Global Phase 3 experience preferred.
• Monitoring Experience preferred